FDA clears Lantheus' Tauklarify PET imaging agent for Alzheimer’s tau detection

Lantheus received FDA clearance for its PET imaging agent Tauklarify, also known as MK-6240, which is designed to help diagnose Alzheimer’s disease by visualizing tau protein deposits.

The clearance restricts use to patients with cognitive impairment being evaluated for Alzheimer’s and does not cover other tau‑related disorders.

The approval was based on two clinical trials that together enrolled more than 500 participants, including individuals with mild cognitive impairment, mild Alzheimer’s dementia, and cognitively normal volunteers.

The decision arrives as Lantheus moves toward an $8 billion acquisition by Curium, underscoring the growing importance of tau imaging in Alzheimer’s assessment.